Elaboration of New Generation Snacks

Snack Food Clinical Trial

Official title:

Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420989
• Other study ID #: casve-nm-15-220
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: December 18, 2019

Study information

• Verified date: February 2023
• Source: Endocrinology and Clinical Nutrition Research Center, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.

Description:

The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.

All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose * insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• presence of metabolic syndrome by (Adult Treatment Panel III) criteria

Exclusion Criteria:

• consume supplements (vitamins, minerals or other dietary components),

• non-restrictive diet

• known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).

• active cancer

Related Conditions & MeSH terms

• Snack Food

Intervention

Other:
• Active snack food
snack enriched with seaweeds and carob
• Control snack food
the same snack food without seaweeds and carob

Locations

Country	Name	City	State
Spain	Daniel de Luis Roman	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Endocrinology and Clinical Nutrition Research Center, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipoproteins	change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl)	change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks
Secondary	carbohydrate metabolism	change of seric carbohydrate parameters markers such as fasting glucose levels (mg/dl)	change from baseline fasting glucose levels (mg/dl) at 8 weeks
Secondary	carbohydrate metabolism	change of seric carbohydrate parameters markers such as insulin levels (UI/L)	change from baseline insulin levels (UI/L) at 8 weeks
Secondary	carbohydrate metabolism	change of seric carbohydrate parameters markers such as HOMA-Insulin resistance (units)	change from baseline HOMA-Insulin Resistance (units) at 8 weeks
Secondary	Blood pressure	change of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)	change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks